Optetrak 200-22-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862040220), received between Nov 14, 2022 and Oct 30, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K932776); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 12 YEARS AND 10 MONTHS POST INITIAL TOTAL KNEE REPLACEMENT (TKA), THE PATIENT PRESENTED TO THE DOCTOR OFFICE COMPLAINING ABOUT THEIR TKA WITH REPORTS OF PAIN, INSTABILITY, AND DISSATISFACTION. THE PATIENT HAD A RECALLED TIBIAL POLY INSERT. THE PATIENT WAS SCHEDULED FOR A LEFT FULL KNEE REVISION VS POLY SWAP. THE PATIENT UNDERWENT A LEFT KNEE REVISION, A FEMORAL COMPONENT REVISION AND A POLY REVISION WAS PERFORMED DUE TO INSTABILITY OF THE KNEE EVEN AT THE THICKEST CRC POLY 19MM. THE PATIENT WAS REVISED TO FEMORAL PS- CC REVISION COMPONENT AND PSC POLY IMPLANT. THE SURGEON WANTED TO UPSIZE THE FEMUR COMPONENT FOR SIZING AND TO CLOSE THE FLEXION GAP KNOWING IT IS OFF LABEL IF KEEPING THE CURRENT TIBIA IMPLANT SIZE. THE TIBIA COMPONENT WAS WELL FIXED, AND THE SURGEON TRAILED A PSC POLY IMPLANT FOR THAT SIZE TIBIA. THE SURGERY WAS PROLONGED APPROXIMATELY 15-30 MINUTES. THE SURGEON WAS HAPPY WITH THE ARTICULATION AND STABILITY. THE PATIENT WAS IMPLANTED WITH THE REVISION FEMORAL COMPONENT AND NEW PSC POLY. THE PATIENT LEFT THE OR STABLE AND WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20568085 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FEMALE PATIENT HAD A LEFT KNEE IMPLANTED IN 2002, AND WAS REVISED ON AN UNKNOWN DATE. THE PATIENT WAS HAVING PAIN, SO THE DOCTOR TOOK OUT THE OPTETRAK CR SIZE 2 15 MM POLY AND PUT IN A TRULIANT CR SIZE 2 17MM POLY. THE ONLY INFORMATION THE REPRESENTATIVE IS ABLE TO PROVIDE IS THAT THE CASE WAS IN 2022 AND THAT THERE IS NO SERIAL NUMBERS FOR THE DEVICES AVAILABLE. THERE WERE NO REPORTED ISSUES DURING THE SURGICAL REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THE DEVICE IS NOT AVAILABLE FOR RETURN, THE HOSPITAL KEPT IT. NO ADDITIONAL INFORMATION.

  Patient problems: Implant Pain; Pain

  MAUDE report 15789813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING